Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01571284 · ClinicalTrials.gov registry record · Phase 3
Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen
A Phase 3 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 781
- Enrollment target
NCT01571284: Completed Phase 3 study, sponsored by Sanofi.
NCT01571284 is a Phase 3 study that has completed, run by Sanofi. The registered enrollment target is 781 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01571284, a Phase 3 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 781 participants
- Enrollment target
Study Summary
Primary Objective: To provide metastatic colorectal cancer participants with access to aflibercept and to document the overall safety in these participants Secondary Objective: To document the Health-Related Quality of Life of aflibercept in this participants population
Primary Outcome
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an adverse event (AE) without regard to possibility of causal relationship with this treatment. A serious AE (SAE): Any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medic
Interventions
- DRUG FOLFIRI
- DRUG AFLIBERCEPT AVE0005
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 781 participants |
| Start Date | 2012-05-30 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 3 |
What the finished NCT01571284 record still lists
NCT01571284 is an interventional study that assigns participants to a tested intervention. The registered 781 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which FOLFIRI is the first listed.
NCT01571284 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01571284 about?
NCT01571284 is a clinical study titled "Safety and Quality of Life Study of Aflibercept in Patients With Metastatic Colorectal Cancer Previously Treated With an Oxaliplatin-Based Regimen". Primary Objective: To provide metastatic colorectal cancer participants with access to aflibercept and to document the overall safety in these participants Secondary Objective: To document the Health-Related Quality of Life of aflibercept in this participants population
What is the current status of trial NCT01571284?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 781 participants. The study started on 2012-05-30. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT01571284?
The interventions under investigation include: FOLFIRI (DRUG), AFLIBERCEPT AVE0005 (DRUG).
Who is sponsoring clinical trial NCT01571284?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01571284's enrollment target sits among peer trials
781 434th of 2000 higher than 1,567 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05046613 · 780 participants
Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant
- NCT05100862 · 780 participants · Phase 3
A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
- NCT05513872 · 780 participants · Phase 1
Overcoming Nicotine Dependence to Enable Quitting
- NCT06310031 · 780 participants · NA
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI